The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:

1. (a)

   Category I: internal production control (module A) set out in Annex IV;

2. (b)

   Category II: F1... type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;

3. (c)

   Category III: F2... type-examination (module B) set out in Annex V, and either of the following:

   1. (i)

      conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;

   2. (ii)

      conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.

   By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.